OncoMatch/Clinical Trials/NCT05155189
A Study to Evaluate Safety and Efficacy of Armored CAR-T Cell Injection C-CAR031 in Advanced Hepatocellular Carcinoma
Is NCT05155189 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including C-CAR031 and Lenvatinib for hepatocellular carcinoma.
Treatment: C-CAR031 · Lenvatinib · Regorafenib (BAY 73-4506) · Durvalumab — A study that aimed to assess the safety and anti-tumor activity of CCAR031 injection in unresectable HCC patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: GPC3 possibly expressed
GPC3 is possibly expressed in tumor tissues
Disease stage
Required: Stage BCLC B, BCLC C (Barcelona Clinic Liver Cancer)
Barcelona Clinic Liver Cancer Stage B or C (BCLC B/C)
Performance status
WHO/ECOG 0–1
Prior therapy
Must have received: systemic therapy (Sorafenib, Lenvatinib, Donafenib, Apatinib, Atezolizumab, Pembrolizumab, Camrelizumab, Sintilimab, Nivolumab, Toripalimab, Tislelizumab, Oxaliplatin, 5-Fu) — advanced HCC
Patients with relapsed / progressive disease after at least one prior standard systemic therapy for HCC, or ineligible to accept/unable to tolerate the systemic therapies. Standard systemic therapies may include targeted drugs (such as Sorafenib, Lenvatinib, Donafenib, Apatinib), immune checkpoint inhibitors (such as Atezolizumab, Pembrolizumab, Camrelizumab, Sintilimab, Nivolumab, Toripalimab, Tislelizumab) or chemotherapeutic drugs (such as Oxaliplatin and 5-Fu).
Cannot have received: cell therapy
History of prior cell therapy
Cannot have received: Lenvatinib (Lenvatinib)
Exception: C-CAR031 plus Lenvatinib group only
Subjects in the C-CAR031 plus Lenvatinib group must ... have not received prior Lenvatinib therapy
Cannot have received: Regorafenib (Regorafenib)
Exception: C-CAR031 combination with Regorafenib group only
Subjects in the C-CAR031 combination with Regorafenib group must ... have not received prior Regorafenib therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L; Lymphocyte count ≥ 0.4 × 10^9/L; Platelet count ≥ 60 × 10^9/L; Hemoglobin ≥ 80 g/L
Kidney function
Serum creatinine ≤ 1.5 × ULN
Liver function
Child-Pugh score ≤ 6; Total bilirubin (TBIL) ≤ 2 × ULN; AST and ALT ≤ 5 × ULN; Prothrombin time (PT): prolonged PT ≤ 4 s
Cardiac function
Left ventricular ejection fraction (LVEF) by echocardiography ≥ 45%
Child-Pugh score ≤ 6; ... LVEF by echocardiography ≥ 45%; ... see full laboratory test requirements
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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